DIFFUNDOX XL 400 MICROGRAM CAPSULES

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DIFFUNDOX XL 400 MICROGRAM CAPSULES
(Tamsulosin hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Diffundox XL is and what it is used for
2. What you need to know before you take Diffundox XL
3. How to take Diffundox XL
4. Possible side effects
5. How to store Diffundox XL
6. Contents of the pack and other information
1. WHAT DIFFUNDOX XL IS AND WHAT IT IS USED FOR
The name of this medicine is Diffundox XL 400 microgram modified-release Capsules (referred to as Diffundox XL
throughout this leaflet). The active ingredient in Diffundox XL is tamsulosin. This is a selective α 1A/1D-adrenoceptor
antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily
through the urethra and facilitating urination. In addition, it diminishes sensations of urge.
Diffundox XL modified-release capsules are used in men for the treatment of the complaints of the lower urinary tract
associated with an enlarged prostatic gland (benign prostatic hyperplasia). These complaints may include difficulty
urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFFUNDOX XL
Do not take Diffundox XL if you
• are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (symptoms may
include: swelling of your face and throat, difficult breathing and/or itching and rash (angio-oedema)).
• have a history of a fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting.
• have severe liver problems.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Diffundox XL if you
• experience dizziness or light-headedness, especially after standing up. Tamsulosin may lower your blood
pressure, causing these symptoms. You should sit or lie down until the symptoms have gone.
• suffer from severe kidney problems. The normal dose of tamsulosin may not have the expected effect when your
kidneys are not functioning normally.
• experience swelling in your face or throat, difficult breathing and/or itching and rash. These are symptoms of
angio-oedema (see section 2, Do not take Diffundox XL). You should stop taking tamsulosin immediately and
contact your doctor. You should not be restarted on tamsulosin.
• are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract). An eye condition
called Intraoperative Floppy Iris Syndrome may occur (see section 4), please inform your eye specialist that you have
previously used, are using, or are planning to use tamsulosin. The specialist can then take appropriate precautions with
respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or
temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.
Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.
Children and adolescents
Do not give this medicine to children or adolescent under 18 years because it does not work in this population.
Other medicines and Diffundox XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other medicines may be affected by tamsulosin. They, in turn, may affect how well tamsulosin works. Tamsulosin can interact with:
• diclofenac, a pain killer and anti-inflammatory medicine. This medicine can speed up the removal of tamsulosin
from your body, thereby shortening the time tamsulosin is effective.
• warfarin, a medicine to prevent blood clotting. This medicine can speed up the removal of tamsulosin from your
body, thereby shortening the time tamsulosin is effective.
• another α1A-adrenoceptor blocker. The combination may lower your blood pressure, causing dizziness or light-headedness.
• medicines that may decrease the removal of Diffundox XL from the body (for example, ketoconazole, erythromycin).
Diffundox XL with food, drink and alcohol
You should take tamsulosin with a glass of water after breakfast or after your first meal of the day.
Pregnancy, lactation and fertility
Pregnancy and lactation
Diffundox XL is not indicated for use in women therefore information on pregnancy and lactation is not relevant.
Fertility
Difficulties with ejaculation have been reported in association with tamsulosin use (see section 4).
Driving and using machines
There is no information on the effects of tamsulosin on the ability to drive and use machines. You should take into
account that tamsulosin may cause dizziness and light-headedness. Only drive or use machines if you feel alright.
3. HOW TO TAKE DIFFUNDOX XL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.
The usual dose is one capsule per day taken after breakfast or after your first meal of the day.
Swallow the capsule whole with a glass of water, while standing or sitting (not while lying down). It is important that
you do not break or crush the capsule as this may influence how well tamsulosin works.
Patients with impaired hepatic or renal function
In patients with renal or mild to moderate hepatic insufficiency it is not necessary to adjust the dose.
Use in children and adolescents
These capsules are not intended for use in children and adolescents.
If you take more Diffundox XL than you should
Your blood pressure may suddenly drop if you take more tamsulosin than you should. You may experience dizziness,
weakness and fainting. Lie down to minimise the effects of low blood pressure and then contact your doctor. Your doctor
may give you medicines to restore you blood pressure and monitor your body function.When necessary your doctor may
empty your stomach and give you a laxative to remove any tamsulosin not yet taken up in the blood from your body.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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